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Animal Drug and Feeds Performance Goals

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Long Term Goal:  Increase access to safe and effective veterinary products, and to safe and nutritious food products, including products for unmet animal and human health needs.
Measure FY Target Result

1.  Promote safe and effective animal drug availability ensuring public and animal health by meeting ADUFA performance goals.  (14020)  (output)

Measure:  Complete review and action on original NADAs & reactivations of such applications received during FY 2007.

2007 90% w/in 200  days 01/09
2006 90% w/in 230 days 01/08
2005 90% w/in 270 days 01/07
2004 90% w/in 295 days 100% w/in 295 days
Data Source: Submission Tracking and Reporting System (STARS). 
Data Validation:  STARS tracks submissions, reflects the Center's target submission processing times and monitors submissions during the developmental or investigational stages and the resulting application for marketing of the product.
Cross Reference:  This performance measure supports HHS Strategic Goal 2.
Long Term Goal:  Prevent harm from products by increasing the likelihood of detection and interception of substandard manufacturing processes and products.

2. Ensure the safety of marketed animal drugs and animal feeds by conducting appropriate and effective surveillance and monitoring activities.  (14009)

Measure 2A:  The number of inspections conducted of registered animal drug and feed establishments. (output)

2007 651 01/08
2006 618 01/07
2005 688 772
2004 703 773
2003 721 847
2002 720 804
Measure 2B:  The number of targeted BSE inspections conducted of all known renderers, protein blenders, and feed mills processing products containing prohibited material. (output) 2007 527 01/08
2006 527 01/07
2005 580 588
2004 647 647
2003 880 880
2002 1305 1282
Data Source: Field Data Systems.
Data Validation: ORA uses two main information technology systems to track and verify field performance goal activities: the Field Accomplishments and Compliance Tracking System (FACTS) and the Operational and Administrative System Import Support (OASIS).  FACTS includes data on the number of inspections; field exams; sample collections; laboratory analyses; and, the time spent on each.  OASIS, which is coordinated with U.S. Customs and Border Protection, provides data on what FDA regulated products are being imported as well as where they are arriving. It also provides information on compliance actions related to imports. FDA is currently developing the Mission Accomplishment and Regulatory Compliance Services (MARCS) system.  MARCS will incorporate the capabilities of these two field legacy systems and include additional functionality.
Cross Reference: This performance measure supports HHS Strategic Goal 2. 

1. Promote safe and effective animal drug availability ensuring public and animal health by meeting ADUFA performance goals.  (14020)

  • Context of Goal:  The Animal Drugs and Feeds Program initiated a user fee program upon passage of the FY 04 appropriation.  The user fee program reflects the implementation of a five-year plan to improve the performance for animal drug review.  ADUFA permits collection of application, product, establishment, and sponsor fees to enhance the animal drug review process.  The benefits provided by the user fee program include:  shorter review times; a more predictable and stable review process; and, an overall reduction in drug development time.

    The FY 04, FY 05, FY 06 and FY 07 targets reflect performance measures consistent with the goals industry has agreed upon for user fees.  The target represents one of the user fee goals and reflects the Center's move toward completion of 90% of specified new animal drug submission reviews within statutorily mandated time frames over a five-year period under ADFUA.

    As mandated by the Federal Food, Drug and Cosmetic Act, a new animal drug may not be sold in interstate commerce unless it is the subject of an approved New Animal Drug Application (NADA).  An approved NADA means the product is safe and effective for its intended use and that the methods, facilities and controls used for the manufacturing, processing and packaging of the drug are adequate to preserve its identity, strength, quality and purity. 

    When a new animal drug application is submitted, CVM evaluates the information contained or referenced in the application.  A determination is made whether the application is approved or not approved.  The sponsor receives a letter informing them either of the approval or describing the deficiencies in the application.  The "days to review" refers to the time it takes to review and take an action on the original submission, or if needed, on subsequent recycles.  This is different from total approval time, which is the time it takes from the original receipt of the application until it is finally approved, which may take more than one review cycle.  This includes the time we spend reviewing the application in each of the review cycles plus the time taken by the sponsor to respond to the issues raised in the not approved letter(s) and to resubmit the application for review.

    FDA is encouraging sponsors to use the phased review process for new animal drug applications.  An Investigational New Animal Drug (INAD) file or submission is established at the request of the sponsor to archive all sponsor submissions for a phased drug review, including: request for interstate shipment of an unapproved drug for study, protocols, technical sections, data sets, meeting requests, memos of conference, and other information.   Phased review has removed a common bottleneck caused by the fact that a sponsor had to wait until all technical sections were reviewed before FDA would render an opinion on the sufficiency of an application.  As a result, the technical section in the application that required the longest review could stymie progress on other sections.  Under phased review, sponsors can coordinate submission of each technical section as the work for that section is completed.  In addition, the direct review program, when linked with phased review, has resulted in significantly improved and more interactive communication between sponsor and reviewer, enabling a more efficient and logical review process.

  • Performance:  The final performance update for FY 2004 indicates FDA exceeded all ADUFA performance goal(s).  FDA reviewed and acted on all seven (7) original NADAs and reactivations of such applications received during FY 2004 within 295 days.  Final performance numbers for FY 2005 will not be available until January 2007.  However, as of September 30, 2005, the preliminary performance assessment for FY 2005 indicates FDA has exceeded the ADUFA goal(s).  Additional information will be available in the FY 2005 ADUFA Performance Report.


ADUFA Performance Cohort FY
Application/Submission Type: Goal:
Review & Act On
Reviewed &
Acted On
As of 9/30/05

New Animal Drug Applications (NADAs)

NADAs & reactivations   FY 04 90% w/in 295 days 7 100%
FY 05 90% w/in 270 days 1 100%
Administrative NADAs & reactivations FY 04 90% w/in 90 days 10 100%
FY 05 90% w/in 85 days 6 100%

New Animal Drug Application Supplements & Reactivations

(Safety & Efficacy)
FY 04 90% w/in 320 days 14 100%
FY 05 90% w/in 285 days 3 100%
Manufacturing FY 04 90% w/in 225 days 363 99%
FY 05 90% w/in 190 days 297 100%

Investigational New Animal Drug (INAD) File Submissions

FY 04 90% w/in 320 days 243 100%
FY 05 90% w/in 285 days 162 100%
Protocols FY 04 90% w/in 125 days 173 99%
FY 05 90% w/in 100 days 148 99%

2. Ensure the safety of marketed animal drugs and animal feeds by conducting appropriate and effective surveillance and monitoring activities. (14009)

  • Context of Goal:  Important features of the risk-based strategy for this goal will be reducing the occurrence of illness and death by focusing resources on manufacturing establishments and other industry components that have the greatest potential for greatest risk. This will result in different inspection frequencies as establishment processes come under control and present lower risk, or as new risks are identified. We note that these goals were reported in previous years as inspection of a fixed percentage of the inventory of establishments. However, given the fluctuation in the inventory, the inspection resources available, and the risk-based prioritization approach that FDA is developing, we believe that it is more appropriate to state the goal in terms of the number of inspections of the highest-risk establishments. We have reformulated the goals accordingly, including prior years for comparability. This strategy will also allow FDA to better address and communicate to our stakeholders about animal drugs and feed safety risks.

    One part of this goal includes inspections done by FDA directly, or through state contracts or partnership agreements, on manufacturers, repackers and relabelers of animal drugs, and manufacturers and growers requiring a Medicated Feed Mill License.  The approximate statutory inspection inventory for this goal is 1,300 firms.

    FDA developed a comprehensive public protection strategy of education, inspection and enforcement action.  These activities will ensure compliance with the Bovine Spongiform Encephalopathy (BSE) feed regulations.  Using an inventory of all known renderers and feed mills processing products containing prohibited material, FDA will continue to conduct annual inspections to determine compliance with the BSE feed rule.  Inventories of these firms may vary from year to year based on changes at the firm such as consolidations, business closures, relocations, etc.

    FDA and states under contract and partnership conduct over 7,000 BSE inspections each year.  FDA will continue to update and improve the inventory of firms with information from the mandatory feed registration system from states and other sources.  The current inventory of renderers and feed mills processing products containing prohibited materials is approximately 530.  The FY 2005 BSE funding increase supported increases in FDA BSE investigational staff; initiated improvements in BSE data collection through the Electronic State Access to FACTS (eSAF) database; funded cooperative agreements in eight (8) states for BSE monitoring and control infrastructure improvements; enhanced state and federal information on the inventory of animal feed firms and firms handling prohibited materials; and strengthened state infrastructure to monitor and respond to feed contamination with prohibited materials.

  • Performance:  In FY 2005, FDA exceeded this goal of 688 by inspecting 772 registered animal drugs and feed establishments; and, FDA completed the inspection of all 588 firms (8 added due to inventory increase) known to process with prohibited materials as part of a concentrated effort to prevent an outbreak of BSE in the U.S.


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